Reversal Dabigatran Anticoagulant Effect With Idarucizumab



Status:Recruiting
Healthy:No
Age Range:Any - 18
Updated:4/4/2019
Start Date:September 7, 2016
End Date:February 28, 2020
Contact:Boehringer Ingelheim Call Center
Email:clintriage.rdg@boehringer-ingelheim.com
Phone:1-800-243-0127

Use our guide to learn which trials are right for you!

Single Dose, Open Label, Uncontrolled, Safety Trial of Intravenous Administration of Idarucizumab to Paediatric Patients Enrolled From Ongoing Phase IIb/III Clinical Trials With Dabigatran Etexilate for the Treatment and Secondary Prevention of Venous Thromboembolism.

The trial objective is to demonstrate the safety of idarucizumab, as assessed by the
occurence of patients with drug related adverse events (including immune reactions) and
all-cause mortality in paediatric venous thromboembolism patients treated with dabigatran in
ongoing clinical trials who require emergency surgery/urgent procedures or patients who have
life-threatening or uncontrolled bleeding which requires urgent intervention, when rapid
reversal of the anticoalugant effect of dabigatran is needed.


Inclusion criteria:

Patients taking dabigatran etexilate in the paediatric trials 1160.106 or 1160.108 are
eligible for this trial if they meet the following criteria:

Group A:

- Overt bleeding judged by the treating physician to require a reversal agent.

- Currently taking dabigatran etexilate in the context of a clinical trial with
dabigatran etexilate (1160.106 or 1160.108).

- Male or female patients from 0 to less than 18 years of age at the time of informed
consent/assent for participation in trial 1160.106 or in trial 1160.108.

- Female patients of childbearing potential (defined as having experienced menarche)
must have followed the contraception requirements according to the dabigatran trial
1160.106 or trial 1160.108 in which they are enrolled.

- Written informed consent provided by the patient (and/or the patient's legally
accepted representative) and assent provided by the patient (if applicable) at the
time of informed consent signature in accordance with Good Clinical Practice (GCP) and
local legislation prior to admission to the trial. If the child is unable to give
assent at the time of the emergency, the assent, when applicable will be obtained as
soon as feasible.

Group B:

- A condition requiring an emergency surgery or invasive procedure where adequate
haemostasis is required. Emergency is defined as need for surgery or intervention
within the following 8 hours.

- Currently taking dabigatran etexilate in the context of a clinical trial with
dabigatran etexilate (1160.106 or 1160.108).

- Male or female patients from 0 to less than 18 years of age at the time of informed
consent/assent for participation in trial 1160.106 or in trial 1160.108.

- Female patients of childbearing potential (defined as having experienced menarche)
must have followed the contraception requirements according to the dabigatran trial
1160.106 or trial 1160.108 in which they are enrolled.

- Written informed consent provided by the patient (and/or the patient's legally
accepted representative) and assent provided by the patient (if applicable) at the
time of informed consent signature in accordance with GCP and local legislation prior
to admission to the trial. If the child is unable to give assent at the time of the
emergency, the assent, when applicable will be obtained as soon as feasible.

Exclusion criteria:

Group A:

- Patients with minor bleeding (e.g. epistaxis, haematuria) who can be managed with
standard supportive care.

- Patients with no clinical signs of bleeding.

- Patients with body weight < 2.5 kg

- Contraindications to trial medication including known hypersensitivity to the drug or
its excipients; i.e. patients with hereditary fructose intolerance who may react to
sorbitol.

- Female patients who are pregnant, nursing, or who plan to become pregnant while in the
trial.

Group B:

- A surgery or procedure which is elective or where the risk of uncontrolled or
unmanageable bleeding is low.

- Patients with body weight < 2.5 kg

- Contraindications to trial medication including known hypersensitivity to the drug or
its excipients; i.e. patients with hereditary fructose intolerance who may react to
sorbitol.

- Female patients who are pregnant, nursing, or who plan to become pregnant while in the
trial.
We found this trial at
7
sites
Las Vegas, Nevada 89109
?
mi
from
Las Vegas, NV
Click here to add this to my saved trials
300 Longwood Ave
Boston, Massachusetts 02115
(617) 355-6000
Boston Children's Hospital Boston Children's Hospital is a 395-bed comprehensive center for pediatric health care....
?
mi
from
Boston, MA
Click here to add this to my saved trials
?
mi
from
Caba,
Click here to add this to my saved trials
?
mi
from
Iowa City, IA
Click here to add this to my saved trials
101 W 8th Ave
Spokane, Washington 99204
(509) 474-3131
Providence Sacred Heart Medical Center & Children's Hospital When Mother Joseph and the Sisters of...
?
mi
from
Spokane, WA
Click here to add this to my saved trials
?
mi
from
Tampa, FL
Click here to add this to my saved trials
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
?
mi
from
Winston-Salem, NC
Click here to add this to my saved trials